Dexcom CLARITY User Guide For Clinics

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1 Dexcom CLARITY User Guide For Clinics LBL , Rev 05 To receive a printed version of this manual, contact your local Dexcom representative Dexcom, Inc. Page 1 of 38

2 Table of Contents 1 Introduction to Dexcom CLARITY Intended Use/Safety Statement Computer and Internet Requirements Terms of Use Privacy Policy and Privacy Practices Proprietary Rights Contact Dexcom About Dexcom CLARITY Access CLARITY Registration Logging Out My Profile Staff Accounts Roles Account Status Adding Staff Accounts Accepting a Staff Account Invitation Managing Staff Accounts Patient Accounts Adding a Patient Editing a Patient Deleting a Patient Navigating the Patient List Patient Data Sharing Inviting a Patient to Share Data Stop Sharing Data Sharing Status Uploading Data Upload Patient Data Upload History Interactive Patient Reports Returning to the Patient List Settings Glucose Time/Target Range Daytime and Nighttime Urgent Low Threshold Viewing Data Dexcom, Inc. Page 2 of 38

3 7.4 Date Range Selection Overview Dashboard Patterns Summaries and Best Day Devices Patterns Pattern Graphs Pattern Occurrences Rebounds Changing the View Health Events Pattern Statistics Considerations Data Trends Data Trends Graph Overlay Data Overlay Graph Daily Data Daily Graph Compare Selecting Date Ranges Compare Trends Compare Overlay Compare Daily Compare Statistics Compare Patterns Statistics AGP Download, Print and Export Reports Download Reports Print Reports Export Reports Export All Patient Data Help, Troubleshooting and Technical Support Help Troubleshooting Network Troubleshooting Technical Support Dexcom, Inc. Page 3 of 38

4 16 Appendix A: Network Configuration Troubleshooting Network Requirements Trusted Websites Loopback Support Dexcom, Inc. Page 4 of 38

5 1 Introduction to Dexcom CLARITY 1.1 Intended Use/Safety Statement The web-based Dexcom CLARITY software is intended for use by both home users and healthcare professionals to assist people with diabetes and their healthcare professionals in the review, analysis, and evaluation of historical CGM data to support effective diabetes management. It is intended for use as an accessory to Dexcom CGM devices with data interface capabilities. Caution: The software does not provide any medical advice and should not be used for that purpose. Home users must consult a healthcare professional before making any medical interpretation and therapy adjustments from the information in the software. Caution: Healthcare professionals should use information in the software in conjunction with other clinical information available to them. 1.2 Computer and Internet Requirements A broadband network connection of 1.5 Mbps or more is required to install the software from the web, upload data or view the online User Guide. It is recommended that you use an appropriate firewall program and an anti-virus program on your computer to protect against viruses, malware and unauthorized access to and use of your computer and the information stored, processed and transmitted by it. CLARITY supports the following minimum configurations: Windows 7, 8 or 10 o 1.3 gigahertz (GHz) processor and 1 gigabyte (GB) free RAM with 100 megabytes (MB) free disk space o Microsoft.NET Framework 4.0 or greater, full version o Display resolution of 1024 x 768 pixels or greater o Chrome 53, Firefox 47, Internet Explorer 9 with Adobe Flash 10, Internet Explorer 10 or 11 run in desktop mode or Microsoft Edge o USB 2.0+ port to connect the USB cable from the patient s optional Dexcom receiver to upload data Mac OSX 10.10, or o 2.3 gigahertz (GHz) processor and 4 gigabytes (GB) free RAM with 100 megabytes (MB) free disk space o Display resolution of 1280 x 800 pixels or greater o Safari 8, 9 or 10, Chrome 53 or Firefox 47 for Mac OSX Dexcom, Inc. Page 5 of 38

6 o USB 2.0+ port to connect the USB cable from the patient s optional Dexcom receiver to upload data Optional computer requirements: Mouse or track pad A PDF reader (for example, Adobe Reader) for viewing, saving, and printing the reports An Excel spreadsheet viewer (for example, Microsoft Excel or Excel Viewer) Printer, for printed copies of reports To run CLARITY, your network must allow the following outbound network traffic, which might require changes to proxy and network configuration: dexcom.eu (and all subdomains) on port 443 dexcom.com (and all subdomains) on port 443 agent.mydiabetesdata.com with DNS loopback support to Terms of Use Use by your clinic of CLARITY and Dexcom services is subject to any written agreement between Dexcom and your clinic, or if none, then the Terms of Use located at: By using this guide, you agree to comply with the applicable terms and conditions in connection with your use of CLARITY, services and this User Guide. 1.4 Privacy Policy and Privacy Practices To read Dexcom s Privacy Policy, go to: Scroll to the bottom of the page, then click Privacy Policy. 1.5 Proprietary Rights CLARITY and this User Guide are by Dexcom, Inc. and its licensors. All Rights Reserved. CLARITY software downloaded onto your computer or other devices might include certain third party software licensed by Dexcom and the notices for which are set forth at: Third party products mentioned in this guide are subject to the rights of their manufacturers and distributors in the products and their trademarks. 1.6 Contact Dexcom For help with a Dexcom CGM system, questions about CLARITY, or to receive a printed version of this manual, contact your local Dexcom representative Dexcom, Inc. Page 6 of 38

7 1.7 About Dexcom CLARITY CLARITY is an accessory to your patient s Dexcom CGM system. It is a software program that allows the transfer of glucose data from your patient s Dexcom CGM system to Dexcom remote servers for data management to assist in your patient s use of the Dexcom CGM system and to assist in your provision of healthcare services to your patient. CLARITY can transfer and manage data from the Dexcom G4 PLATINUM, Dexcom G4 PLATINUM with Share and the Dexcom G5 Mobile CGM System (all of which are referred to as Dexcom CGM systems). After the glucose data is uploaded to CLARITY, the information is displayed in graphs to help you analyze patient trends and patterns in glucose. Data reports can be saved or printed by you and saved, ed and printed by users. CLARITY displays glucose data from a Dexcom CGM system 3 hours after the data is captured. This means that the most recent data you view in CLARITY is at least 3 hours old. 2 Access CLARITY To access CLARITY on the web, go to On the Log in page: Enter your Dexcom account username and password. Click Login. or Click Register Now if you do not have a clinic account, then see Section Registration Every clinic must be registered by an authorized representative to be accessed by healthcare professionals. By registering the clinic, you become an Administrator for the CLARITY account. See Section 3.1 to learn more about account roles. Your CLARITY account is specific to your geographical area. Accounts created in the EU will not work within, or with a United States created account. United States created accounts will not work within, or with an account created in the EU Dexcom, Inc. Page 7 of 38

8 To register your clinic: Select your language from the dropdown in the top right corner. Select your country from the Country dropdown. Click Submit. Have an authorized representative complete the registration form. Click Submit. Click Complete Registration from the activation sent to the representative. Enter a username and password for yourself. Click Complete my registration. Click OK. 2.2 Logging Out At any time, you can log out of CLARITY. Click Log out at the top of the page. This is useful if multiple account users access the same computer. 2.3 My Profile To change language, units of measurement and password settings, click My Profile at the top of the page. All profiles are initially set the language and units of measurement the clinic registered in. You can also reset your password at any time. 3 Staff Accounts The Staff Accounts page displays all clinic user account names, addresses, user roles, and account status. If you have just created your clinic s CLARITY account, you will see only your own account listed. 3.1 Roles CLARITY offers two different kinds of user roles: Standard Users and Administrators. Standard Users access and manage the Patient List, upload CGM data and view patient reports. Administrators access and manage the Patient List and Staff Accounts. They upload CGM data, view patient reports and invite new clinic users Dexcom, Inc. Page 8 of 38

9 3.2 Account Status The options for account status are: Invited: Account owner has been sent an invitation to use CLARITY. Active: Account is available for use. Invitation Suspended: Invitation to use CLARITY has expired. Expired: No logins for 90 days. Locked: Exceeded allowed login attempts. Suspended: Account is disabled. 3.3 Adding Staff Accounts As an Administrator, you can invite other healthcare professionals to use CLARITY. To invite staff: Click Staff Accounts. Click Add Staff Account. Enter the healthcare professional s name and address. Select Standard User or Administrator to assign the user role and privileges. Click Save to send an activation to the invited user. Click Add another Staff Account or Close. New users must accept the invitation and create a username and password to activate their account. The user will appear in the Staff Accounts list as Invited until activation Dexcom, Inc. Page 9 of 38

10 3.4 Accepting a Staff Account Invitation After an administrator adds you to the clinic account, you will receive an invitation from CLARITY. You will need a new invitation if you do not complete your registration before the expiration date noted. To complete your registration: 1. Click Complete Registration from the activation sent to you. 2. Enter a username and password for yourself. 3. Click Complete my registration. 4. Click OK. 3.5 Managing Staff Accounts Administrators can edit names, , account status and roles for staff accounts. To make edits: Click Staff Accounts. Locate the user you want to edit, then hover your cursor next to their account status until an Edit icon appears. Click Edit. Make the desired changes. Click Save. Click OK on the success page. You can re-send invitations to create an account from the Edit Staff Account page by checking the box for it. Administrator users cannot change their own user role from Administrator to Standard User. Another Administrator must change the role for them Dexcom, Inc. Page 10 of 38

11 You cannot permanently delete a user account. You can only suspend accounts to remove access. 4 Patient Accounts The Patient List displays patients associated with your CLARITY clinic account. All CLARITY clinic users have access to this page. For each patient, you can upload or export CGM data during visits, save or print reports, view interactive reports, edit or delete their information and invite them to share their CGM data. To access these options, click the patient name. Adding a patient to your clinic s CLARITY Patient List does not create a CLARITY account for that patient. Patients must create their own account through the home user portal if they want to view or share CGM data uploaded at the clinic. See Section 6 for more information about sharing. 4.1 Adding a Patient To add a patient: Click Patient List. Click Add new patient. Enter the patient s name, date of birth and optional patient ID. Click Save. Click Upload data, then see Section 6. or Click Share data, then see Section 5. or Click Add another patient. or Click Close. The Patient ID is optional and can be composed of alpha or numeric characters to identify patients within your clinic Dexcom, Inc. Page 11 of 38

12 4.2 Editing a Patient To edit a patient: Click Patient List. Click the patient s name you want to edit. Click Edit at the bottom of the window. Make the desired changes. Click Save. Click OK on the success page. 4.3 Deleting a Patient Deleting a patient deletes all CGM data uploads and sharing, and cannot be undone. To delete a patient: Click Patient List. Click the patient s name you want to edit. Click Delete at the bottom of the window. Click the Yes I want to delete this patient box. Click Delete. Click Close on the success page. 4.4 Navigating the Patient List There are two ways to navigate the Patient List to find a specific patient: Search or Sort. Search uses the search bar at the top of the Patient List to find a specific patient. To search for a patient: Enter a patient s last name or Patient ID. Press the Enter key on your keyboard to start the search. Sort indexes by patient last name, date of birth (DOB) or Patient ID in ascending or descending orders. By default, patients are sorted alphabetically by last name. To sort the patient list: Click PATIENT NAME, DOB, or PATIENT ID on the green bar. Click your selection again to sort in the reverse order. If you have more than 10 patients, you access them using the page numbers at the bottom of the patient list Dexcom, Inc. Page 12 of 38

13 5 Patient Data Sharing Patients must give permission to share their uploaded data by accepting a sharing invitation from your clinic. Data is not shared until the patient creates or logs into their CLARITY account to accept the invitation to share. See Section 5.1 for more information. After the patient accepts their sharing invitation, data uploaded by the patient from a Dexcom receiver or Dexcom G5 Mobile app will be available for viewing at the clinic. Data uploaded at your clinic from that moment on is available to the patient on their account. Patients or clinics can stop sharing data at any time. All data uploaded by receiver to the clinic s CLARITY account will still be accessible at the clinic. This data will not be accessible from the patient s CLARITY account after sharing is stopped. All data streamed from the Dexcom G5 mobile app or uploaded from the receiver to the patient s personal CLARITY account will not be accessible to the clinic after sharing is stopped. Patients continue to see their own data within their personal CLARITY account via receiver upload or streaming from their Dexcom G5 Mobile app. 5.1 Inviting a Patient to Share Data Use CLARITY to invite patients to share data with your clinic. Provide an invitation to patients in print or by . Invitations provide a sharing code that patients enter on their personal CLARITY accounts. Once they enter the code, the accounts will automatically share data between them. Invitations are generated in your clinic s default language. To create an invitation: Click Patient List. Click the patient s name you want to invite. Click Share data at the bottom. Click Print an Invitation to print the invitation. or Click an Invitation, then enter the patient s address. Click Invite. Click Close on the success page Stop Sharing Data To stop sharing data with a patient: Dexcom, Inc. Page 13 of 38

14 Click Patient List. Click the patient s name you want to stop sharing with. Click Stop sharing data at the bottom. The patient s name will still appear on the Patient List for your reference. 5.2 Sharing Status To determine whether a patient is sharing data with your clinic, view the Data Sharing column of the Patient List for that patient. If they are not sharing, the entry displays Off. If they are sharing, the entry displays On. If you have invited them to share but they haven t yet accepted, the entry displays Invited. 6 Uploading Data You can upload a patient s CGM data from their Dexcom receiver each time they are at your clinic. If a patient is using the Dexcom G5 Mobile app, data is continuously uploaded and viewable when sharing is permitted. See section 5 for information about Sharing. It is possible to use both a smartphone and a receiver to provide CGM data. The smartphone system streams data to the CLARITY server, where that data is made available for reports after three hours. The Dexcom receiver requires connection to a computer to upload the data periodically. If the patient uses a smartphone part of the time and a receiver part of the time, then CLARITY needs data from both to provide accurate statistics. 6.1 Upload Patient Data When you upload from a patient s Dexcom receiver at the clinic, the data is immediately viewable from their entry in the Patient List. To upload data for each patient: Click Patient List. Click the desired patient s name. Click Upload data. Connect the CGM per the instructions provided on the screen. Click Upload. Click Save or print report. or Click Go to interactive reports. or Review the upload history at the bottom of the page Dexcom, Inc. Page 14 of 38

15 6.2 Upload History The bottom of the Upload Data page shows the most recent 10 uploads. The table includes upload location including date and time, device type and device serial number. 7 Interactive Patient Reports In CLARITY, you view patient data reports in organized graphs with several views and filters. You can access the reports directly after uploading patient data, or do the following at any time: Click Patient List. Click the desired patient s name. Click Go to interactive reports. 7.1 Returning to the Patient List To return to the Patient List while viewing interactive reports, click Click here to return to your clinic s Patient List at the top of any reports page. 7.2 Settings Use the Settings page to customize glucose time periods for target ranges. Changes you make to patient settings only apply at the clinic and do not change any CGM settings Dexcom, Inc. Page 15 of 38

16 7.2.1 Glucose Time/Target Range Customize the upper and lower limits for the glucose target range by doing one of the following: Click a gray circle icon and drag it up or down to set the desired glucose levels for patient target range. or Select the time and thresholds of the glucose level for both Day and Night, from the drop-down lists below the chart. Throughout CLARITY, the upper limit line is always yellow, and the lower limit line is always red. The colors may appear different based on your monitor settings Daytime and Nighttime Changes you make to a patient s settings only apply at the clinic. Customize the day and night by doing one of the following: Click a gray circle icon and drag it left or right to set when the day begins and ends. or Select a start and end time for both Day and Night, from the drop-down lists below the chart Urgent Low Threshold Choose 50 or 55mg/dL as the threshold for Urgent Low displays within CLARITY reports. Changing this setting does not change the Dexcom CGM Urgent Low threshold which is set at 55mg/dL. 7.3 Viewing Data To view data, click Overview, Patterns, Data, Compare and Statistics. 7.4 Date Range Selection CLARITY presents data in a default date range of the most recent 14 days of data. The green date bar displays the current date range. To change the date range: Click anywhere on the green bar to open the selector window. Click 7, 14, 30 or 90 for Number of days (most recent). or Click inside the Start Date and End Date boxes to choose dates for a custom view, then click OK Dexcom, Inc. Page 16 of 38

17 8 Overview The Overview page shows a glucose summary dashboard of statistics, pattern summaries and the patient s best glucose day for the date range selected. It also provides information about the Dexcom CGM system used to upload the data shown. 8.1 Dashboard The Overview page includes a summarized dashboard of key measurements from the selected date rage including: Estimated A1C: Estimated A1C (ea1c) is not a lab test and is only related to the average glucose as determined from your CGM data. Alternatively, A1C is a laboratory measurement that reflects the average level of glucose over approximately the last 3 months and is reported as a percentage. CLARITY determines an ea1c as the average glucose from a minimum number of days with a minimum duration of CGM wear time. o For reports with fewer than 20 days in the selected date range, ea1c is calculated from a minimum of 12 days that maintain CGM wear time of 66% or more Dexcom, Inc. Page 17 of 38

18 o For reports spanning more than 20 days in the selected date range, ea1c is calculated from at least 60% of all the days in the selected date range that maintain CGM wear time of 66% or more. If the above conditions are not met for the selected date range, ea1c will display as N/A. The ea1c is a simple calculation determined from the average CGM glucose. It is not a lab test and ea1c may be different than the A1C value from either a clinic s lab equipment or from blood drawn for lab analysis. Average glucose (CGM): The average of all the glucose readings in the selected date range. Standard deviation (CGM): Standard Deviation (SD) reflects the amount of variability in CGM readings. The larger the SD, the larger the variability. Hypoglycemia risk: This calculation estimates risk for severe hypoglycemia. It is based on a combination of the number of times glucose was low, the magnitude of the low glucose and for how long there was low glucose. Experiencing frequent lower measured glucose values for short durations has more impact than minimal hypoglycemia for longer periods but with less frequency. Having more frequent lows for longer durations and at lower glucose levels carries a high risk for severe hypoglycemia. The hypoglycemia risk complements the patient s A1C measurements. Patients can have low or high A1C and still be at low, medium or high hypoglycemia risk. The impact of hypoglycemic risk on patients and diabetes management should be reviewed by a healthcare professional. The hypoglycemia risk estimation is calculated from a minimum number of days with a minimum duration of CGM wear time as follows: o For reports with fewer than 20 days in the selected date range, hypoglycemia risk is calculated from a minimum of 12 days that maintain CGM wear time of 66% or more. o For reports spanning more than 20 days in the selected date range, hypoglycemia risk is calculated from at least 60% of all the days in the selected date range that maintain CGM wear time of 66% or more. Time in range: The percentage of time that glucose levels are in low, target and high ranges. CLARITY displays time in range from both daytime and nighttime ranges. Each Dexcom CGM reading is compared against the custom glucose target range and assigned a category of High, In Range, Low, or Urgent Low. Readings are tallied, then percentages for each category are calculated Dexcom, Inc. Page 18 of 38

19 Sensor Usage: Provides a high-level view of Dexcom CGM device usage. o Days with CGM data shows the number of days during the reporting period with at least 50% CGM readings. o Avg. calibrations per day displays the average number of calibrations per day, entered by the patient, during the reporting period. Only days with at least 50% CGM readings are included. 8.2 Patterns Summaries and Best Day The Overview page shows up to four patterns identified in the data. To view a summarized pattern on the Patterns page, click the box of the pattern for detailed graphs and statistics. Limits for low and high glucose levels are modified on the Settings page. See Section 7.2 for more information. A patient s best glucose day is the day the patient was most within the target range of the selected date range. Click the best glucose day box for a detailed view. 8.3 Devices Details about a patient s Dexcom CGM system including Serial Number, last upload and current alert settings are located under Devices of the Overview page Dexcom, Inc. Page 19 of 38

20 9 Patterns The Patterns page provides graphical patterns, statistics and considerations for highs, lows and patient best day within the selected date range. These are the same patterns summarized on the Overview page. There will always have a Best Day tab to review. Click each tab to see details. 9.1 Pattern Graphs Each pattern is represented by a series of graphs, dated by each time the pattern was found in the selected date range, or a pattern occurrence. Each graph includes: A 24-hour timeline on the bottom x-axis. Scale for glucose readings on the left y-axis. Target range limits on the right y-axis. CGM lines that connect the individual CGM glucose readings. Values associated with each CGM reading viewed by moving your mouse along the CGM lines Dexcom, Inc. Page 20 of 38

21 Target glucose ranges shown by the colored lines that run parallel to the x-axis, as determined in Settings, Section 4. The yellow line is the upper limit and the red line is the lower limit. Significant daily data that is used to indicate the pattern, highlighted in the white background columns. Health events as recorded on the Dexcom CGM system shown with an icon below the x-axis and viewed by hovering your cursor over each icon. Calibration events entered into the Dexcom CGM system shown by the gray circle C icon, when the calibration toggle is active Pattern Occurrences A pattern occurrence is a period of glucose data that matches a larger pattern of similar periods of glucose data. For example, if the data shows a pattern of nighttime lows; one of those nighttime lows would be an occurrence. Days may have multiple occurrences of a pattern. Pattern occurrence are the white columns. Gray areas of the graph are not part of the pattern. Glucose values and events are viewed by moving your mouse over any part of the graph and hovering. A letter marks each pattern occurrence. This letter is displayed at the top of the graph, above the white column, and displayed at the left of the graph with the times of the occurrence. Column and left side pattern occurrences will be highlighted in a blue color when you hover your cursor over occurrences Dexcom, Inc. Page 21 of 38

22 9.1.2 Rebounds A rebound is when a pattern occurrence is followed immediately by the opposite a high after a low, or a low after a high. The number of rebounds in the glucose data set is noted in the summary before the graphs Changing the View You can view or hide both CGM data and Calibration events from the graphs. By default, both events are on as indicated by a green slider. Off is indicated by a white slider. To turn these events off so they do not appear on the graphs: Click the CGM slider. Click the Calibrations slider Health Events Health events your patient enters into their Dexcom CGM system appear on the graphs. For example, if they enter exercise around noon on June 13 th, that event shows up on all graphs that include June 13 th, such as this Best Day graph. Each event is marked with an icon displayed below the x-axis and viewed by hovering your cursor over the icon. If they enter multiple events within the same one-hour window, the icons display stacked on top of each other. Hover over one of the icons to view all the hourly information. 9.2 Pattern Statistics Statistics for patterns found from the selected date range include Average glucose (CGM), Standard deviation (CGM) and Time in range. 9.3 Considerations Based on the patterns of the selected date range, some possible considerations are provided at the bottom of the Patterns page Dexcom, Inc. Page 22 of 38

23 10 Data The Data page allows you to see glucose data for the selected date range in trends, overlay and daily views. The top section of the page displays view options, filters and graphs. The bottom section displays the content from the Overview page Trends Data Trends allows you to see glucose trends at different times of day over the selected date range. For example, you might see that glucose levels are stable during mornings but are less stable during afternoons. Trends is the default view of Data. To filter the Trends data: 1. Click Trends. 2. Click Days, Time of Day, Events and Usage filters as needed. 3. Click Apply. You must click Apply every time you change a filter to update the graph. 4. Click the CGM and Calibrations sliders to toggle them on or off. See section Trends Graph The Trends graph includes: A 24-hour timeline along the bottom x-axis. Scale for glucose readings on the right y-axis. CGM lines that trace CGM glucose data readings Dexcom, Inc. Page 23 of 38

24 Values associated with each CGM readings viewed by moving your mouse along the CGM lines. Target glucose ranges shown by the colored lines that run parallel to the x-axis and values as set in Settings, Section 4, on the left y-axis. The yellow line is the upper limit and the red line is the lower limit. Calibration events entered into the Dexcom CGM system shown by the gray circle C icon, when the calibration toggle is active. The yellow and red shaded bars show patterns of clinically significant hyper- or hypoglycemia, respectively. Three factors determine clinical significance: Time spent in hyper- or hypoglycemia Scale of hyper- or hypoglycemia Frequency of hyper- or hypoglycemia The darkest shaded bars are the most significant areas of hyper- and hypoglycemia. Lighter shaded bars show other patterns of hyper- and hypoglycemia, including data not clinically significant Overlay Data Overlay displays one week of data in each graph with colored lines to represent a single day s data over time. For example, if you chose a date range of 10 days and do not apply any filters, you would see two graphs, one with seven lines and one with three Dexcom, Inc. Page 24 of 38

25 To filter the Overlay data: 1. Click Overlay. 2. Click Days, Time of Day, Events and Usage filters as needed. 3. Click Apply. You must click Apply every time you modify a filter. 4. Click the CGM and Calibrations sliders to toggle them on or off. See section Overlay Graph The Overlay graph has several components: A 24-hour timeline along the bottom x-axis. Scale for glucose readings on the left y-axis. CGM lines: Each line on the Overlay graph represents a different day s data. A key above the graph shows which line corresponds with which day. Use these CGM lines to spot trends and compare data from different days in the selected date range. Hover: Put the cursor anywhere on a CGM line and rest it there for a moment to get detailed glucose information from that point in time. Target glucose ranges shown by the colored lines that run parallel to the x-axis and values as set in Settings, Section 4, on the right y-axis. The yellow line is the upper limit and the red line is the lower limit Dexcom, Inc. Page 25 of 38

26 Calibration events entered into the Dexcom CGM system shown by the gray circle C icon, when the calibration toggle is active Daily Data Daily displays glucose data in graphs by the day over the selected time range. Daily graphs are displayed with the most recent day first. Use the numbers along the bottom of the last graph to load previous days. To filter the Daily data: Click Daily. Click Days, Time of Day, Events and Usage filters as needed. Click Apply. You must click Apply every time you access each filter to update the graph. Click the CGM and Calibrations sliders to toggle them on or off. See section Daily Graph The Daily graphs include: A 24-hour timeline along the bottom x-axis. Scale for glucose readings on the left y-axis. CGM lines that trace CGM glucose data readings. Values associated with each CGM readings viewed by moving your mouse along the CGM lines. Target glucose ranges shown by the colored lines that run parallel to the x-axis, as determined in Settings, Section 4. The yellow line is the upper limit and the red line is the lower limit. Areas between the CGM line and a target range limit are colorcoded accordingly Dexcom, Inc. Page 26 of 38

27 Health events as recorded on the Dexcom CGM system, shown with an icon below the x-axis and viewed by hovering your cursor over each icon. Calibration events entered into the Dexcom CGM system shown by the gray circle C icon, when the calibration toggle is active. If the black trace line in the graph has interruptions or stops, then the Dexcom CGM system did not record glucose data during that time. 11 Compare The Compare page is divided into two columns containing graphs, statistics, patterns and devices to compare within selected date ranges Selecting Date Ranges Each column has its own date range selector. You can compare up to 90 days of data. Use the numbers located below the last graph to view more graphs in your selected date range. The green date bars display the current date ranges for comparison. To change the ranges for each column: 1. Click anywhere on the green bar to open the selector window. 2. Click 7, 14, 30 or 90 for Number of days (most recent). or Click inside the Start Date and End Date boxes to choose dates for a custom view, then click OK. You can compare the graphs through the Trends, Overlay, or Daily views and apply filters. To change the data views and filters: Click Trends, Overlay, or Daily to select the view. Click Days, Time of Day, Events and Usage filters as needed Dexcom, Inc. Page 27 of 38

28 Click Apply. You must click Apply every time you access each filter to update the graph. Click the CGM and Calibrations sliders to toggle them on or off. See section for more information. The sliders are located below the graphs Compare Trends In the Trends view, see side-by-side glucose trends throughout the day over the selected date ranges. These graphs include the same features as the Trends Graph. See Section for more information Compare Overlay In the Overlay view, compare glucose data by the day over the selected time range. These graphs include the same features as the Overlay Graph. See Section for more information Compare Daily In the Daily view, see side-by-side Daily 24-hour graphs for the selected date range. These graphs include the same features as the Daily Graph. See Section for more information Compare Statistics All Compare views include statistics, which are shown below the graphs. These statistics are similar to those shown on the Overview page. See Section 8 for more information. Statistics in the right column are marked with arrows to indicate changes from the left column values. An arrow pointed up means the statistic on the right is higher than the same statistic on the left. An arrow pointed down means it is lower Dexcom, Inc. Page 28 of 38

29 11.6 Compare Patterns Click the name of the pattern to view the time range, number of events and rebounds of the pattern. Patterns that were resolved from the left column are marked on the right column with strikethrough green text and a checkmark icon. New patterns in the right column are highlighted with a NEW icon. Best Days are always included for both selected date ranges. 12 Statistics Statistics for CGM data are shown either Daily or Hourly with standard and advanced views for the date range selected. Daily statistics are calculated values for the individual day of the week over the date range selected. For example, if the date range is for 14 days, all the CGM values collected on the two Mondays would be used in the Monday calculations. Hourly statistics are calculated values for the individual hour of the day over the date range selected. For example, if the date range is for seven days, all CGM values collected for each individual hour for each of the seven days would be used in the calculations Dexcom, Inc. Page 29 of 38

30 Click Daily or Hourly for standard views, then click the Advanced checkbox if you want to view all the statistics. Daily and Hourly both have the same statistics and include: Time in Range: The percentage of time that glucose levels are in low, target and high ranges. CLARITY displays time in range from both daytime and nighttime ranges. Each Dexcom CGM reading is compared against the custom glucose target range and assigned a category of High, In Range, Low, or Urgent Low. Readings are tallied, then percentages for each category are calculated. # Readings: Total number of CGM readings. Min: Minimum is the lowest CGM reading. Mean: The average of CGM readings. Max: Maximum is the highest CGM reading. Quartile 25: The CGM reading where 25% of all readings fell at or below this value, after ranking all values from lowest to highest. Median: The midpoint of all CGM readings where half the readings fall above. Quartile 75: The CGM reading where 75% of all readings fell at or below this value, after ranking all values from lowest to highest. IQR: Inter Quartile Range (IQR) is the difference between the Quartile 75 and Quartile 25 readings. Std. Dev.: Standard Deviation (SD) reflects the amount of variability in CGM readings. The larger the SD, the larger the variability in CGM readings. IQ Std. Dev.: Inter Quartile Standard Deviation (IQSD) removes the top 25% and bottom 25% of CGM before calculating the SD Dexcom, Inc. Page 30 of 38

31 SD Mean: Standard Deviation of the Mean (SD Mean) estimates variability by dividing the SD by the square root of the number of values. %CV: Percentage of Coefficient of Variation (%CV) is calculated by dividing the glucose Standard Deviation by the mean glucose. %CV is the standardized measure that describes the magnitude of sample values and the variation within them. 13 AGP The Ambulatory Glucose Profile (AGP) is a licensed, standardized glucose report created by the International Diabetes Center (IDC). AGP provides a big picture view of your diabetes management and is only one part of understanding your glucose patterns. The report is divided into these sections: Glucose Statistics summarize the glucose values from the selected date range. o Glucose Exposure: The average of all the glucose readings in the selected date range. o Glucose Ranges: Percentage of time spent in each of the glucose ranges. o Glucose Variability: How far readings are from the average. o Data Sufficiency: Percentage of time CGM readings were provided. Ambulatory Glucose Profile readings are combined to make a one day, 24-hour picture Dexcom, Inc. Page 31 of 38

32 o 50% Median: Half of glucose values are above this line and half are below. o 25/75%-IQR: Half of the glucose values are between these lines and half are outside these lines. o 10/90%: 80% of glucose values are between these lines. Daily Glucose Profiles contain single day views of glucose values from the selected date range. 14 Download, Print and Export Reports You can download, print and export reports for each patient. All reports are generated in the default language and units of measurement for your profile. Your patient might request a report in different language or unit of measurement. To send a report with different settings, go to My Profile. See Section 2.5 for more information Download Reports To download a report as a PDF: Click Patient List. Click the desired patient s name. Click Save or print report. Click anywhere on the green bar to select a date range. Click 7, 14, 30 or 90 for Number of days (most recent). or Click inside the Start Date and End Date boxes to choose dates for a custom view, then click OK. Click at least one report to download. Click Save as PDF. Click Close on the completed page Dexcom, Inc. Page 32 of 38

33 14.2 Print Reports To print a report: Click Patient List. Click the desired patient s name. Click Save or print report. Click anywhere on the green bar to select a date range. Click 7, 14, 30 or 90 for Number of days (most recent). or Click inside the Start Date and End Date boxes to choose dates for a custom view, then click OK. Click at least one report to download. Click Print Report Export Reports You can export raw glucose data values, calibration values and events to an Excel spreadsheet, saved to your computer. This generates a.csv file. To export a report: Click Patient List. Click the desired patient s name. Click Export. Click anywhere on the green bar to select a date range. Click 7, 14, 30 or 90 for Number of days (most recent). or Click inside the Start Date and End Date boxes to choose dates for a custom view, then click OK. Click Export. Click Close on the confirmation page Dexcom, Inc. Page 33 of 38

34 14.4 Export All Patient Data You can export all patients raw glucose data values, calibration values and events in one Excel spreadsheet, saved to your computer. This generates a.csv file. To export all data report: Click Patient List. Click Export all data at the top of the patient list. Click Export. Click Close on the confirmation page. 15 Help, Troubleshooting and Technical Support 15.1 Help To get help with CLARITY, click Help at the top of the page and click one of the following: Click User Guide to view, print or save this guide in PDF format. Click Contact Us to view FAQs or to Dexcom. Click Uninstall to remove CLARITY from your computer Troubleshooting If you are having trouble accessing CLARITY, try these troubleshooting steps: If you forget your password, go to the login screen and click Forgot your password? to have it ed to you. If you forget your username, go to the login screen and click Forgot your username? to have it ed to you. Contact your local IT support, as needed for your clinic account setup. Your local IT support can ensure that your firewall settings allow you to access CLARITY and privileges to install software. Make sure your computer is connected to the Internet throughout the session. If the computer loses that connection, it might not display the screens properly Dexcom, Inc. Page 34 of 38

35 Check that the computer s operating system and browser are supported. See Section 1 for more information. Know where downloaded files are stored. This will make finding reports and downloads easier. Make sure that no other glucose data software or Dexcom software is open. If any such programs are open, they could cause stalls or failures during uploads from a CGM. Make sure the following URLs are included in any trusted website browser lists: o o o Network Troubleshooting See Section 14 for important information about required network configurations Technical Support For help with Dexcom CGM system, questions about CLARITY, or to receive a printed version of this manual, contact your local Dexcom representative Dexcom, Inc. Page 35 of 38

36 16 Appendix A: Network Configuration Troubleshooting This information is intended for users who are behind corporate firewalls or use Proxy Servers for internet connectivity. Please work with your local IT support to ensure proper network configuration Network Requirements Running Dexcom Web Uploader software for clinics requires internet connectivity for outbound and inbound HTTPS/SSL traffic as listed below: dexcom.eu (and all subdomains) on port 443 dexcom.com (and all subdomains) on port 443 agent.mydiabetesdata.com with DNS loopback/localhost support to Trusted Websites For networks using Trusted sites configurations, include the following entries in Internet Options > Security > Trusted sites > Sites or within managed Group Policy Configuration: Loopback Support The site agent.mydiabetesdata.com must be treated as a local intranet site, bypassing Proxy Servers. This may require DNS loopback support to localhost , along with an exception within the corporate network configuration setup to allow agent.mydiabetesdata.com to bypass Proxy Server and be treated as a local intranet site. For clients where Group Policy enforcement is not in use or clients that allow for local Dexcom, Inc. Page 36 of 38

37 Dexcom CLARITY User Guide for Clinics LBL , Rev 05 Internet Options changes, the following steps can be used as a guide for proper configuration. For Local Intranet: Navigate to Internet Options > Security > Local intranet > Sites. Uncheck Include all sites that bypass the proxy server. For Proxy Settings Exceptions: Navigate to Internet Options > Connections > LAN Settings. Check the Use Proxy server for your LAN box. Click Advanced. Enter agent.mydiabetesdata.com in the Exceptions box. Click OK Dexcom, Inc. Page 37 of 38

38 Dexcom, Inc. MediTech Strategic, Consultants B.V Sequence Drive Maastrichterlaan San Diego, CA NL 6291 EN Vaals Tel Fax Outside US: Contact your local Dexcom representative Australian Sponsor Emergo Australia Level 20, Tower II Darling Park 201 Sussex Street Sydney, NSW 2000 Australia Dexcom, Inc. Dexcom, Dexcom CLARITY, Dexcom G4 PLATINUM and the Dexcom G5 Mobile CGM System are either registered trademarks or trademarks of Dexcom, Inc. in the United States and/or other countries. All other product or company names that may be mentioned in this publication are tradenames, trademarks or registered trademarks of their respective owners Dexcom, Inc. Page 38 of 38

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